RISPERIDONE VIATRIS 3 mg FILM-COATED TABLETS

2. What you need to know before you take Risperidone Viatris

Do not take Risperidone Viatris:

• If you are allergic to risperidone or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before taking Risperidone Viatris:

• If you are taking furosemide (a 'diuretic' used to reduce swelling and fluid retention caused by various medical problems, including heart or liver disease).
• If you have any heart disease. Such as if you have a weakness in the heart muscle (heart failure), have had a heart attack, if you are prone to having low blood pressure or if you are taking medications for blood pressure. Risperidone may cause low blood pressure and it may be necessary to adjust your dose.
• If you, or someone in your family, has a history of irregular heartbeat, as this medicine has been associated with potentially serious changes in heart rhythm.
• If you have any factors that may favor the appearance of an embolism, such as high blood pressure, cardiovascular disorders, or problems with the blood vessels in the brain.
• If you have any factors that may favor the appearance of a blood clot, such as if you are a smoker, or have smoked, or if you are likely to be immobile for a long period (for example, after surgery or illness).
• If you, or someone in your family, has a history of blood clots, as these medications have been associated with the formation of blood clots.
• If you have, or have had, low levels of white blood cells in the blood, especially if these have appeared when taking other medications.
• If you have ever experienced involuntary movements of the tongue, mouth, and face.
• If you have ever had a disease with the following symptoms: fever, muscle stiffness, sweating, or decreased level of consciousness (also known as Neuroleptic Malignant Syndrome).
• If you have Parkinson's disease (a brain disease that affects movement, such as tremors, postural rigidity, slow movements, and displacements) or dementia (a general decline in all areas of mental ability, such as memory loss and other mental abilities), especially dementia with Lewy bodies (abnormal protein aggregates that develop within nerve cells in Parkinson's disease).
• If you are diabetic or at risk of developing diabetes (you may have high blood sugar levels).
• If you have epilepsy.
• If you are a man and have ever had a prolonged or painful erection.
• If you have problems controlling your body temperature, are prone to excessive heat, or are, or may be, exposed to high temperatures or engage in extreme exercise.
• If you are, or become, dehydrated or have low blood volume (hypovolemia) during treatment.
• If you have low levels of potassium or magnesium in the blood.
• If you have kidney problems.
• If you have liver problems.
• If you have an abnormally high level of the hormone prolactin in the blood or if you have a tumor that may be dependent on prolactin.

If you are not sure if this is your case, consult your doctor or pharmacist before taking risperidone.

During treatment

Risperidone may cause changes in the number of white blood cells, which help fight infections, so your doctor may perform blood tests before and after treatment.

Risperidone may cause weight gain. Significant weight gain can negatively affect your health. Your doctor should regularly measure your body weight.

As diabetes or worsening of pre-existing diabetes has been seen in patients taking risperidone, your doctor should check if you have sugar in your blood. Patients with pre-existing diabetes should regularly check their blood sugar levels.

Risperidone often increases the levels of a hormone called prolactin. This can cause side effects such as menstrual disorders or fertility problems in women or breast swelling in men (see Possible side effects). If these side effects appear, it is recommended to evaluate prolactin levels in the blood.

If you are going to undergo eye surgery, inform your doctor or hospital staff that you are taking this medicine. During cataract surgery (a clouding of the eye's lens), this medicine may affect the pupil or iris (the colored part of the eye), which could cause eye damage.

Elderly patients with dementia

In elderly patients with dementia, there is an increased risk of embolism or mini-embolism (also known as transient ischemic attack or TIA). You should not take risperidone if you have dementia caused by an embolism.

During treatment with risperidone, you should visit your doctor frequently.

You should seek immediate medical attention if you or your caregiver notice a sudden change in your mental state, sudden weakness, numbness in the face, arms, or legs, especially if it is on one side, vision problems, or difficulty speaking, even if it is only for a short period. These may be signs of an embolism.

Children and adolescents

Before starting treatment for behavioral disorders, other possible causes for aggressive behavior should be ruled out.

Before starting treatment, your body weight or your child's body weight may be measured and may be regularly checked during treatment.

If fatigue appears during treatment, a change in the time of administration may improve attention difficulties.

A small, inconclusive study has reported an increase in height in children who took risperidone, but it is not known if this is a drug effect or due to another reason.

Taking Risperidone Viatris with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription and herbal medicines.

It is especially important that you tell your doctor or pharmacist if you are taking any of the following medicines:

• Medicines that act on your brain to, for example, help you calm down (benzodiazepines) or some pain medications (opioids), medications for allergies (some antihistamines), as risperidone may increase the sedative effect of all of them.
• Medicines that can change the electrical activity of your heart, such as those used for malaria (quinine, mefloquine), heart rhythm problems (such as quinidine, disopyramide, procainamide, propafenone, amiodarone, sotalol), allergies (antihistamines), some antidepressants (such as paroxetine, fluoxetine, sertraline, fluvoxamine, tricyclic antidepressants (such as amitriptyline), tetracyclic antidepressants (such as maprotiline) or other medications for mental health conditions (such as paliperidone or phenothiazines, used to treat psychosis or to calm down).
• Medicines that can cause a decrease in heart rate, such as beta-blockers or verapamil (used to treat high blood pressure or angina).
• Medicines that can cause a decrease in potassium or magnesium levels in the blood (for example, certain diuretics).
• Medicines for high blood pressure. Risperidone may cause a decrease in blood pressure.
• Medicines for Parkinson's disease (such as levodopa).
• Medicines that increase the activity of the central nervous system (psychostimulants, such as methylphenidate).
• Tablets for fluid retention (diuretics) used to treat heart problems or swelling of some parts of your body due to fluid accumulation (such as furosemide or chlorothiazide). Risperidone taken alone or in combination with furosemide may increase the risk of embolism or death in elderly patients with dementia.

The following medicines reduce the effect of risperidone:

• Rifampicin (a medicine for treating some infections).
• Carbamazepine, phenytoin (medicines for epilepsy).
• Phenobarbital.

If you start or stop taking these medicines, you may need a different dose of risperidone.

The following medicines increase the effect of risperidone:

• Cimetidine, ranitidine (stomach acid blockers).
• Itraconazole and ketoconazole (medicines used to treat fungal infections).
• Some medicines used to treat HIV/AIDS, such as ritonavir.

If you start or stop taking these medicines, you may need a different dose of risperidone.

If you are not sure if this is your case, consult your doctor or pharmacist before taking risperidone.

Taking Risperidone Viatris with food, drinks, and alcohol

You should avoid consuming alcoholic beverages during treatment with risperidone.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether you can take it.

The following symptoms may appear in newborns of mothers who have been taking risperidone in the last trimester (the last three months of pregnancy): tremors, muscle stiffness, agitation, difficulty breathing, and difficulty feeding. If your baby presents any of these symptoms, you may need to contact your doctor.

Risperidone may increase the levels of a hormone called “prolactin”, which can affect fertility (see section 4, “Possible side effects”).

Driving and using machines

During treatment with risperidone, dizziness, fatigue, and vision problems may occur. Do not drive or use tools or machines without first consulting your doctor.

Risperidone Viatris contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet;it is essentially “sodium-free”.

Risperidone Viatris 2 mg and 6 mgcontainsorange yellow

This medicine may cause allergic reactions because it contains orange yellow (E110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Risperidone Viatris

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will tell you the amount you should take and for how long. This depends on your disorder and varies from person to person.

The recommended dose is as follows:

For the treatment of schizophrenia

Adults

• The initial recommended dose is 2 mg per day, which may be increased to 4 mg per day on the second day of treatment.
• Depending on how you respond to treatment, your doctor may adjust your dose.
• Most people feel better with daily doses of 4 to 6 mg.
• The total daily dose may be divided between one or two administrations per day. Your doctor will inform you which dose is most convenient for you.

Elderly patients

• The initial recommended dose is usually 0.5 mg twice a day.
• The dose may be gradually increased by your doctor to 1 mg or 2 mg twice a day.
• Your doctor will inform you which dose is most convenient for you.

Use in children and adolescents

• Children and adolescents under 18 years of age should not be treated with risperidone for schizophrenia.

For the treatment of mania

Adults

• The initial recommended dose is usually 2 mg once a day.
• The dose may be gradually adjusted by your doctor depending on how you respond to treatment.
• Most people feel better with doses of 1 to 6 mg once a day.

Elderly patients

• The initial recommended dose is usually 0.5 mg twice a day.

• The dose may be gradually adjusted by your doctor to 1 mg or 2 mg twice a day depending on how you respond to treatment.

Use in children and adolescents

• Children and adolescents under 18 years of age should not be treated with risperidone for mania.

For the treatment of prolonged aggression in patients with Alzheimer's dementia

Adults (including elderly patients)

• The initial recommended dose is usually 0.25 mg twice a day.
• The dose may be gradually adjusted by your doctor depending on how you respond to treatment.
• Most people feel better with 0.5 mg twice a day. Some patients require a dose of 1 mg twice a day.
• Treatment in patients with Alzheimer's dementia should not be prolonged for more than 6 weeks.

For the treatment of behavioral disorders in children and adolescents

The dose depends on the child's weight:

For children weighing less than 50 kg:

• The initial recommended dose is usually 0.25 mg once a day.
• The dose may be increased every other day to 0.25 mg per day.
• The usual maintenance dose is 0.25 mg to 0.75 mg once a day.

For children weighing 50 kg or more:

• The initial recommended dose is usually 0.5 mg once a day.
• The dose may be increased every other day to 0.5 mg per day.
• The usual maintenance dose is 0.5 mg to 1.5 mg once a day.

The duration of treatment in patients with behavioral disorders should not be prolonged for more than 6 weeks.

Children under 5 years of age should not be treated with risperidone for behavioral disorders.

Patients with kidney or liver problems

Regardless of why you are taking this medicine, all initial and subsequent doses should be reduced by half. The increase in dose should be slower in these patients.

Risperidone should be used with caution in this group of patients.

How to take Risperidone

• Swallow the tablet with plenty of water.
• Risperidone can be taken with or without food.

The tablet can be divided into equal doses.

If you take more Risperidone Viatris than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

In case of overdose, you may feel drowsy or tired, have abnormal body movements, problems standing or walking, feel dizzy due to low blood pressure, or experience a rapid or abnormal heart rate or seizures.

If you forget to take Risperidone Viatris

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your usual dosing schedule. If you forget two or more doses, contact your doctor.
• Do not take a double dose (two doses at the same time) to make up for missed doses.

If you stop taking Risperidone Viatris

Do not stop taking this medicine unless your doctor has told you to do so. It is possible that the symptoms will reappear. If your doctor decides to stop the treatment, they should gradually decrease the dose over a few days.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Consult your doctor or go to the emergency department of a hospitalimmediately if:

Frequent (may affect up to 1 in 10 people):

• Develops lung infections, including severe lung infections such as pneumonia - you may have a very high temperature, cough with phlegm that may be bloody or frothy and discomfort.

Uncommon (may affect up to 1 in 100 people):

• Experiences a sudden change in mental state, sudden fatigue or numbness in the face, arms or legs, especially on one side, vision problems, or difficulty speaking, even for a short period. These can be signs of a stroke, mini-stroke (TIA, transient ischemic attack) or decreased blood flow to the brain.
• Experiences an abnormal heart rhythm, such as heart flutter (fibrillation) or very slow or abnormal heartbeat (heart block). This can be caused by abnormal electrical conduction of the heart and can be seen as an abnormal tracing of the heart's electrical activity (ECG). In some cases, it can be potentially life-threatening.
• Does not respond to stimuli (change in internal or external environment), has a low level of consciousness or becomes unconscious, or suffers from seizures (convulsions).
• Presents rhythmic involuntary movements of the tongue, mouth, and face. Withdrawal of risperidone may be necessary.
• Develops diabetes - a condition where the body is unable to control blood sugar levels properly. You may feel very thirsty, but with high urine output, have an increased appetite despite feeling tired and lethargic. If left untreated, it can cause coma or potentially life-threatening complications of uncontrolled diabetes.
• Experiences a higher number of infections such as sore throat, mouth ulcers, etc., which can be caused by a decrease in white blood cells in the blood, including those that help protect against bacterial infections.
• Develops a lung infection caused by inhaling food into the airways or has lung congestion (e.g., due to accumulation of phlegm).
• Presents a skin infection (usually in the fat layers of the thigh and buttocks (cellulitis).
• Has difficulty urinating or incomplete emptying of the bladder.
• Has severe constipation, which can be due to intestinal obstruction or severe hardening or compaction of feces.

Rare (may affect up to 1 in 1,000 people):

• Presents a severe rash, itching or hives on the skin, swelling of the face, lips, tongue or throat, shortness of breath, difficulty breathing, dizziness, and shock. These can be signs of a severe allergic reaction or angioedema.
• Presents blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can travel through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, seek medical attention immediately.
• Presents fever, muscle stiffness, sweating, or decreased level of consciousness (a disorder called "neuroleptic malignant syndrome"). Immediate medical treatment may be necessary.
• If you experience a prolonged or painful erection. This is called priapism. Immediate medical treatment may be necessary.
• Presents severe stomach pain that reaches the back. This can be a symptom of pancreatitis.
• Develops increased eye pressure (glaucoma), which can cause vision problems and, in the long term, serious vision problems.
• Low sodium levels in the blood, which can cause feelings of weakness and confusion with muscle pain. This can be due to inappropriate secretion of the hormone (ADH) that causes water retention in the body and dilutes the blood, reducing the amount of sodium. This can be associated with excessively high water intake (more than 2 liters of water per day).
• Suffers from severe fatigue or muscle pain, which can be due to muscle tissue breakdown (rhabdomyolysis).

Very Rare (may affect up to 1 in 10,000 people):

• Suffers from loss of appetite, unexplained weight loss, nausea, vomiting, stomach pain, difficulty breathing, slow heart rate, unusual muscle pain, or feeling weak, tired, or uncomfortable. These can be signs of a rare, potentially life-threatening complication of uncontrolled diabetes called diabetic ketoacidosis.

Consult your doctor immediately if you experience any of the adverse effects described above.

The following adverse effects may also occur:

Very Common (may affect more than 1 in 10 people):

• Parkinsonism. A medical term that includes many symptoms. Each individual symptom may occur with a frequency of less than 1 in 10 people. Parkinsonism includes: increased salivation or water in the mouth, musculoskeletal stiffness, drooling, jerking when bending joints, slow body movements, reduced or problematic movements, facial expressionlessness, muscle tightness, stiff neck, muscle stiffness, small, rapid, and shuffling steps, lack of habitual arm movement when walking, persistent blinking in response to slapping on the forehead (an abnormal reflex).
• Headaches, difficulty falling asleep or staying asleep.
• Somnolence, sleep.

Common (may affect up to 1 in 10 people):

• Fatigue, unusual weakness (asthenia), feeling of tiredness, somnolence, or lack of energy (lethargy), restlessness, inability to remain seated, anxiety, depression, agitation, dizziness, feeling of tiredness, sleep disorders.
• Vomiting, diarrhea, constipation, nausea, acidity or indigestion, stomach pain or discomfort, sore throat, dry mouth, toothache.
• Weight gain, increased body temperature (high fever), increased appetite, loss of appetite.
• Shortness of breath, flu, blurred vision, eye infection or allergic reaction that can produce a sticky secretion, sinus infection, nasal or sinus congestion, nosebleeds, cough.
• Urinary tract infection, bedwetting, inability to control urine (incontinence), inability to control when to urinate.
• Tremor, muscle spasms, involuntary movements of the face, arms, or legs, repetitive movements or abnormal postures associated with muscle contractions, joint and muscle pain, back pain.
• Fluid retention (e.g., swelling of arms and legs), pain in the limbs.
• Rashes, skin redness, ear infections.
• Rapid heart rate, chest pain, high blood pressure.
• Falls.
• Increased prolactin hormone levels in the blood.

Uncommon (may affect up to 1 in 100 people):

• Excessive water consumption, thirst, fecal incontinence, gas, hoarse voice, and voice disorders.
• High blood sugar.
• Bladder infection, viral infection, and other infections, tonsil infection, stomach infection, fungal infection of the nails.
• Drop in blood pressure when standing up, low blood pressure, dizziness when changing posture, awareness of heartbeat, decreased heart rate.
• Pain when urinating, increased frequency of urination.
• Confusion, attention disorder, excessive sleepiness, nightmares, nervousness, euphoria (mania).
• Increased liver enzymes, low hemoglobin or red blood cell count (anemia), increased eosinophils (special white blood cells), increased creatine phosphokinase in blood, decreased platelet count (blood cells that stop bleeding), increased cholesterol in blood.
• Muscle weakness, excessive agitation associated with muscle spasms and tremors, ear pain, neck pain, joint inflammation, abnormal postures, joint stiffness, chest discomfort.
• Skin lesions, skin disorders, dry skin, intense itching of the skin, acne, hair loss, eczema (skin inflammation) that can be caused by mites, skin discoloration, increased skin thickness, flushing, sensations like pins and needles, decreased skin sensitivity to touch or pain, inflammation of fatty skin.
• Amenorrhea, sexual dysfunction, erectile dysfunction, ejaculation disorders, breast secretion, breast enlargement in men, breast pain or discomfort, decreased libido, irregular or delayed menstruation, vaginal discharge.
• Fainting, gait disorders (way of walking), slowness, weight loss, decreased appetite leading to malnutrition and weight loss, feeling of depression, balance disorders, allergy, chills, abnormal coordination, altered taste.
• Painful sensitivity to light, increased ocular blood flow, dry eyes, increased tearing.
• Crepitus in the lungs, speech problems, difficulty swallowing, harsh or whistling sounds when breathing.
• Ringing in the ears, sensation of spinning and dizziness (vertigo), facial edema.

Rare (may affect up to 1 in 1,000 people):

• Difficulty reaching orgasm, breast enlargement or inflammation, heat, breast tenderness.
• Dandruff.
• Coldness in the limbs, tongue swelling, lip inflammation, hardening of some parts of the body, such as the skin.
• Lack of movement or response while awake (catatonia).
• Sleepwalking.
• Sleep-related eating disorder.
• Crusts on the eyelids, eye rotations, eye movement problems, complications during cataract surgery.
• Lack of emotion.
• Withdrawal syndrome.
• Decreased body temperature.
• Rapid and shallow breathing, sleep breathing problems, sinus arrhythmia (a normal variation in heart rate caused by breathing).
• Head tremor.
• Yellowing of the skin and eyes (jaundice).
• Sugar (glucose) in the urine, decreased blood sugar, increased triglycerides in blood (a type of fat).

There have also been reports of decreased blood pressure when standing up with risperidone, which is associated with a very high increase in heart rate.

Other Adverse Effects in Children and Adolescents

In general, it is expected that adverse effects in children will be similar to those that occurred in adults.

The following adverse effects were reported more frequently in children and adolescents (5 to 17 years) than in adults: feeling drowsy or less alert, fatigue (tiredness), headache, increased appetite, vomiting, common cold symptoms, nasal congestion, abdominal pain, dizziness, cough, fever, tremor (shaking), diarrhea, and urinary incontinence (loss of bladder control).

Reporting of Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) https://notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Risperidona Viatris

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the blister pack and on the packaging after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines that are no longer needed in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Risperidona Viatris

The active ingredient is risperidone. Each film-coated tablet contains 3 mg of risperidone.

The other ingredients are:

Core of the tablet:Lactose monohydrate, pregelatinized cornstarch, microcrystalline cellulose (E-460), magnesium stearate, anhydrous colloidal silica, sodium lauryl sulfate.

Coating:Hypromellose (E-464), propylene glycol (E-490), titanium dioxide (E-171), talc (E-553B), and quinoline yellow (E-104).

Appearance of the Product and Package Contents

Yellow, round, biconvex, film-coated tablet marked with a "3" on one side and a score line on the other side.

Package Sizes

Blisters containing 20, 28, 30, 50, 56, 60, or 100 film-coated tablets.

Perforated unit-dose blisters containing (28 × 1), (30 × 1), (56 × 1), (60 × 1), or (100 × 1) film-coated tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

McDermott Laboratories Limited t/a Gerard Laboratories

35/36 Baldoyle Industrial Estate,

Grange Road, Dublin 13.

Ireland

or

Mylan Hungary Kft.

Mylan utca 1

H-2900 Komárom

Hungary

or

Mylan Dublin

Newenham Court

Northern Cross

Malahide Road

Dublin 17

Ireland

or

Logiters, Logistica Portugal, S.A.

Estrada dos Arneiros, 4

Azambuja, 2050-306

Portugal

or

Mylan Germany GmbH

Zweigniederlassung Bad Homburg Benzstrasse 1,

61352 Bad Homburg v. d. Höhe,

Germany

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Risperidon Mylan 3 mg filmtabletten

Spain: Risperidona Viatris 3 mg film-coated tablets EFG

Italy: Risperidone Mylan Pharma

Netherlands: Risperidon Mylan 3 mg filmomhulde tabletten

Portugal: Risperidona Mylan 3 mg film-coated tablet

Date of the last revision of this leaflet:July 2019

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/